Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000989741
Ethics application status
Approved
Date submitted
3/09/2013
Date registered
5/09/2013
Date last updated
28/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of kiwifruit supplementation on neutrophil and sperm function in young adult males low in vitamin C: implications for immunity and fertility
Scientific title
The effects of kiwifruit supplementation on neutrophil and sperm function in young adult males low in vitamin C: implications for immunity and fertility
Secondary ID [1] 283128 0
None
Universal Trial Number (UTN)
U111-1146-5950
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunity 289978 0
Fertility 289979 0
Condition category
Condition code
Inflammatory and Immune System 290353 290353 0 0
Normal development and function of the immune system
Reproductive Health and Childbirth 290354 290354 0 0
Fertility including in vitro fertilisation
Diet and Nutrition 290369 290369 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be supplemented with two export-grade gold kiwifruit/day for four weeks. Compliance will be monitored by measuring plasma vitamin C levels every week.

An extension period will comprise supplementation with 250 mg/d vitamin C tablets for two months. Compliance will be determined by counting remaining tablets.
Intervention code [1] 287849 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290385 0
Neutrophil function:
- apoptosis quantified by double staining of cells with propidium iodide and Annexin V-FITC, and fluorescence-activated cell sorting (FACS)
- bacterial killing by neutrophils cocultured with S. aureus and measuring loss of bacterial colony-forming units using the fluorescent membrane potential dye DiOC2
- neutrophil chemotaxis assayed using Falcon Fluoroblok inserts and a fluorescence plate reader
- neutrophil extracellular traps production measured using the membrane impermeable DNA binding dye Syntox Green and fluorescence microscopy
Timepoint [1] 290385 0
pre- and post-intervention (4 weeks)
Primary outcome [2] 290386 0
Sperm function:
- WHO fertility criteria e.g. volume, count, motility, vitality
- metabolic activity of mitochondria measured using a Seahorse XF extracellular analyser
- oxidative stress determined by oxidative state of peroxiredoxins measured using SDS-PAGE and western blotting
- sperm chromatin structure assay measured using FACS
Timepoint [2] 290386 0
Pre-intervention, post-intervention (4 weeks) and post vitamin C tablet supplementation period (3 months)
Primary outcome [3] 290387 0
Vitamin C content of plasma, neutrophils and semen measured using HPLC with electrochemical detection
Timepoint [3] 290387 0
Pre-intervention and post-intervention (4 weeks) for plasma, neutrophil and semen vitamin C levels, and post vitamin C tablet supplementation period (3 months) for plasma and seminal vitamin C levels only
Secondary outcome [1] 304391 0
General health (SF-36 questionnaire)
Timepoint [1] 304391 0
Pre- and post-intervention (4 weeks)
Secondary outcome [2] 304436 0
Urate and allantoin content of plasma and semen measured using UHPLC with stable isotope dilution mass spectrometry
Timepoint [2] 304436 0
Pre- and post-intervention (4 weeks)
Secondary outcome [3] 304437 0
Myeloperoxidase content of plasma and semen measured using ELISA
Timepoint [3] 304437 0
Pre- and post-intervention (4 weeks)

Eligibility
Key inclusion criteria
Male aged 18-35 years
Non-smoker
Plasma vitamin C <50 umol/L
Residing in Christchurch for the duration of the study
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
allergy/intollerance to kiwifruit
recent smoker (within previous year)
taking vitamin C supplements (within past 3 months)
taking prescription medication (within past 3 months)
excessive alcohol consumption (>21 std drinks/week)
high fruit and vegetable consumption (>5 servings/d)
diabetes mellitus
bleeding disorgers
fainting due to fear of needles

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2013
Actual
15/10/2013
Date of last participant enrolment
Anticipated
Actual
11/12/2013
Date of last data collection
Anticipated
Actual
17/02/2014
Sample size
Target
18
Accrual to date
Final
14
Recruitment outside Australia
Country [1] 5354 0
New Zealand
State/province [1] 5354 0
Canterbury

Funding & Sponsors
Funding source category [1] 287879 0
Government body
Name [1] 287879 0
Ministry of Business, Innovation & Employment (MBIE)
Country [1] 287879 0
New Zealand
Funding source category [2] 287880 0
Commercial sector/Industry
Name [2] 287880 0
Zespri International Ltd
Country [2] 287880 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
PO Box 4345
2 Riccarton Avenue
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 286606 0
None
Name [1] 286606 0
Address [1] 286606 0
Country [1] 286606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296204 0
Health and Disability Ethics Committees
Ethics committee address [1] 296204 0
Ethics committee country [1] 296204 0
New Zealand
Date submitted for ethics approval [1] 296204 0
15/08/2013
Approval date [1] 296204 0
22/08/2013
Ethics approval number [1] 296204 0
13/STH/105

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42594 0
Prof Margreet Vissers
Address 42594 0
University of Otago, Christchurch
2 Riccarton Avenue
PO Box 4345
Christchurch 8140
Country 42594 0
New Zealand
Phone 42594 0
64 3 364 1524
Fax 42594 0
Email 42594 0
[email protected]
Contact person for public queries
Name 42595 0
Anitra Carr
Address 42595 0
University of Otago, Christchurch
2 Riccarton Avenue
PO Box 4345
Christchurch 8140
Country 42595 0
New Zealand
Phone 42595 0
64 3 364 0649
Fax 42595 0
Email 42595 0
[email protected]
Contact person for scientific queries
Name 42596 0
Anitra Carr
Address 42596 0
University of Otago, Christchurch
2 Riccarton Avenue
PO Box 4345
Christchurch 8140
Country 42596 0
New Zealand
Phone 42596 0
64 3 364 0649
Fax 42596 0
Email 42596 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEnhanced human neutrophil vitamin C status, chemotaxis and oxidant generation following dietary supplementation with vitamin C-rich SunGold kiwifruit.2015https://dx.doi.org/10.3390/nu7042574
Dimensions AIMarginal Ascorbate Status (Hypovitaminosis C) Results in an Attenuated Response to Vitamin C Supplementation2016https://doi.org/10.3390/nu8060341
EmbaseElevated seminal plasma myeloperoxidase is associated with a decreased sperm concentration in young men.2017https://dx.doi.org/10.1111/andr.12327
N.B. These documents automatically identified may not have been verified by the study sponsor.